Early Antiviral Therapy for Critically Ill HIV Infected Patients
Early Antiretroviral Therapy for Critically Ill HIV Infected Patients
1 other identifier
interventional
115
1 country
1
Brief Summary
The aim of the study is to verify the effect of HAART in critically ill HIV infected patients. The current practice is to begin antiviral therapy after ICU discharge, when the condition of the patient is more stable. The investigators hypothesis is that the investigators can improve outcome of these patients with earlier antiviral therapy in the ICU. The investigators just have retrospective studies in this scenario. After admission to ICU, patients are assigned to one of two arms: early HAART (within 5 days of ICU admission) or conventional therapy (initiation of HAART after ICU discharge). The following data will be collected: demographic variables, CD4 count, viral load, drug toxicity, opportunistic infection, hemodialysis, mechanical ventilation and vasoactive drug. The patients will be followed to determine ICU mortality, hospital mortality and 6-month mortality.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Jan 2012
Longer than P75 for phase_4
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
October 17, 2011
CompletedFirst Posted
Study publicly available on registry
October 20, 2011
CompletedStudy Start
First participant enrolled
January 1, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2015
CompletedStudy Completion
Last participant's last visit for all outcomes
June 30, 2016
CompletedApril 12, 2018
April 1, 2018
4 years
October 17, 2011
April 10, 2018
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Hospital mortality
It is a estimative of length of hospital stay
4 weeks
Secondary Outcomes (1)
6-month mortality
6 months
Study Arms (2)
Early antiviral therapy
EXPERIMENTALConventional therapy
ACTIVE COMPARATORInterventions
Eligibility Criteria
You may qualify if:
- HIV infection
- CD4 cell count less than 350 cells/mm3 within 3 months prior to study entry OR CD4 cell count between 350 cells/mm3 and 500 cells/mm3 if age \> 55 years, coinfection with HBV or HCV, neoplasia, viral load \> 100,000 copies/ml or elevated cardiovascular risk OR AIDS-defining illness
You may not qualify if:
- Regular use of HAART
- Pregnant
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Hospital Nossa Senhora da Conceicao
Porto Alegre, Rio Grande do Sul, Brazil
Related Publications (1)
Boniatti MM, Pellegrini JAS, Marques LS, John JF, Marin LG, Maito LRDM, Lisboa TC, Damiani LP, Falci DR. Early antiretroviral therapy for HIV-infected patients admitted to an intensive care unit (EARTH-ICU): A randomized clinical trial. PLoS One. 2020 Sep 21;15(9):e0239452. doi: 10.1371/journal.pone.0239452. eCollection 2020.
PMID: 32956419DERIVED
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
October 17, 2011
First Posted
October 20, 2011
Study Start
January 1, 2012
Primary Completion
December 31, 2015
Study Completion
June 30, 2016
Last Updated
April 12, 2018
Record last verified: 2018-04